Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Conditions: Obstructive Ventilation Disorder; Pulmonary Emphysema; COPD
• Interventions: Device: impulse oscillometry; Device: multiple breath washout test; Device: body plethysmography

• Registration Number: NCT02827721
• Lead Sponsor: Universitätsmedizin Mannheim

Brief Summary

Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of COPD.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24
• Primary Completion: 2020-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• known or suspected COPD
• known or suspected obstructive ventilation disorder
• pulmonary healthy controls

Exclusion Criteria

• pregnancy
• inability to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD	impulse oscillometry	Patients with known or suspected COPD Patients with known or suspected obstructive ventilation disorder
COPD	body plethysmography	Patients with known or suspected COPD Patients with known or suspected obstructive ventilation disorder
pulmonary healthy controls	impulse oscillometry	Patients without known or suspected pulmonary disease
COPD	multiple breath washout test	Patients with known or suspected COPD Patients with known or suspected obstructive ventilation disorder
pulmonary healthy controls	body plethysmography	Patients without known or suspected pulmonary disease
pulmonary healthy controls	multiple breath washout test	Patients without known or suspected pulmonary disease

Primary Outcome Measures

Name	Time	Method
lung clearance index (LCI) as determined by multiple breath washout	30 minutes
airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry	30 minutes

Secondary Outcome Measures

Name	Time	Method
repeatability of lung clearance index (LCI)	30 minutes

Trial Locations

Locations (1)

University Medical Center Mannheim; 🇩🇪 Mannheim, Germany